Skip to main content
OpenTrials
Completed

NCT Number: NCT07731841

Transcranial Magnetic Stimulation for Freezing of Gait in Parkinson's Disease

This study evaluated transcranial magnetic stimulation (TMS) for freezing of gait in patients with Parkinson's disease. Participants with Parkinson's disease and freezing of gait received conventional TMS protocols, and their clinical, gait, and neurophysiological outcomes were assessed. Patients who did not achieve sufficient improvement after conventional TMS were further treated with a combined primary motor cortex and cerebellar stimulation protocol. The study aimed to identify factors associated with differential response to conventional TMS and to explore whether cerebellar stimulation could improve symptoms in treatment-resistant patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) a score of ≥ 1 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Item 13 or FOGQ Item 3, with freezing episodes during gait initiation, turning, or navigating narrow spaces confirmed by two independent investigators; (2) a stable antiparkinsonian medication regimen for at least four weeks before enrollment; (3) right-handedness; (4) age ≥ 40 years; (5) no current use of antidepressants, anxiolytics, or antipsychotic agents. Antiparkinsonian medications and their dosages remained unchanged throughout the study.

Exclusion criteria

  • (1) personal or family history of atypical parkinsonian syndromes, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, Wilson's disease, and vascular parkinsonism; (2) coexisting movement disorders or other neurodegenerative conditions; (3) gait-impairing disorders such as primary progressive freezing of gait; (4) impaired consciousness, or visual, auditory, or language deficits that precluded full assessment; (5) severe systemic diseases, including cardiopulmonary disorders, hepatic or renal insufficiency, malignancies, and hematologic or autoimmune diseases; (6) prior cranial surgery or deep brain stimulation (DBS); (7) pregnancy; (8) history of epilepsy; (9) severe cognitive impairment with a Mini-Mental State Examination (MMSE) score below 24; and (10) other contraindications to TMS.

Treatment and study plan

Primary Motor Cortex Transcranial Magnetic Stimulation

Device

Bilateral lower-limb primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Treatment was administered once daily for five consecutive days per week over two weeks.

Spinal Cord Magnetic Stimulation

Device

Transcutaneous spinal magnetic stimulation was delivered over the T10-T12 segment at 1 Hz, with 1500 pulses. Stimulation intensity was adjusted to produce visible lower-limb muscle contraction.

SMA TMS

Device

Supplementary motor area stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 1000 pulses. Treatment was administered as an add-on protocol combined with bilateral lower-limb primary motor cortex stimulation.

Cerebellar Intermittent Theta-Burst Stimulation

Device

Bilateral cerebellar intermittent theta-burst stimulation was delivered using 50-Hz triplets at 5 Hz, with 2-second trains every 10 seconds and a total of 2700 pulses over 15 minutes. This intervention was administered to patients who were treatment-resistant to conventional TMS.

Primary outcomes

  1. Freezing of Gait Questionnaire Improvement Rate

    Time frame: Baseline and 1 month after treatment

    The improvement rate of the Freezing of Gait Questionnaire was calculated as [(pre-treatment FOGQ score at baseline - post-treatment FOGQ score at one-month follow-up) / pre-treatment FOGQ score at baseline] × 100%. Participants with an improvement rate of at least 30% were classified as treatment responsive.

Secondary outcomes

  1. Unified Parkinson's Disease Rating Scale Part III Score

    Time frame: Baseline, within 24 hours after treatment, and 1 month after treatment

    Motor symptoms were assessed using the Unified Parkinson's Disease Rating Scale Part III.

  2. Upper-Limb Short-Interval Intracortical Inhibition

    Time frame: Baseline and within 24 hours after treatment

    Upper-limb short-interval intracortical inhibition was assessed using paired-pulse transcranial magnetic stimulation and expressed as the conditioned/unconditioned motor evoked potential amplitude ratio.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Mechanisms of Differential Response to Transcranial Magnetic Stimulation in Freezing of Gait in Parkinson's Disease and Cerebellar Stimulation Intervention for Treatment-Resistant Patients

Acronym: PD-FOG-TMS

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.